
Toshiba America Medical Systems, In.C
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DRAD-3000E, RADREX-I is an FDA 510(k)-cleared medical device (K073165) manufactured by Toshiba America Medical Systems, In.C. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 2007. Regulation: 8.